NCT04582214

Oscillation and Lung Expansion Therapy in Patients With COVID-19

A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized With COVID-19

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Hill-Rom · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19

Detailed description

This is a randomized prospective open-label cohort study in patients with COVID-19 to evaluate the impact of Oscillation and Lung Expansion (OLE) therapy using The MetaNeb® System on the hospital length of stay in patients hospitalized and receiving heated high-flow oxygen therapy for COVID-19 infection. The active treatment group will consist of patients who are treated OLE therapy while on heated high-flow oxygen therapy . Results from subjects in the active treatment group will be compared to results from patients treated with standard care with no OLE therapy.

Conditions

• COVID-19
• Oscillation and Lung Expansion

Interventions

Type	Name	Description
DEVICE	MetaNeb® System	The intervention device use in this study is The MetaNeb® System (Hill-Rom; St. Paul, MN). It is an FDA 510k cleared device (k124032), powered by compressed gas, that delivers oscillation and lung expansion (OLE) therapy using both continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP). The device also provides supplemental oxygen when used with compressed oxygen and can deliver aerosol therapy during CPEP and/or CHFO. The therapy is indicated for mobilization of secretions, lung expansion therapy and the treatment and prevention of pulmonary atelectasis. The device also provides supplemental oxygen when used with compressed oxygen.

Timeline

• Start date: 2020-09-28
• Primary completion: 2022-04-30
• Completion: 2022-06-30
• First posted: 2020-10-09
• Last updated: 2022-05-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study